Dermasensor Inc recalls Model 10101 software version 3.0.2 for potential incorrect results or delayed referrals in skin cancer diagnosis. Affected units have specific serial numbers.
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Dermasensor Inc is recalling its Model 10101 device with software version 3.0.2 because it might give incorrect results or delay proper referrals for skin cancer patients. This could lead to missed diagnoses or delayed treatment.
The device might not meet specifications, leading to incorrect results or delays in referring patients who need skin cancer treatment. This could affect diagnosis accuracy and timely care.
Physicians using the DermaSensor device for skin cancer lesions may be affected. Those with the specific model and software version are most at risk.
Check for model number 10101, software version 3.0.2, and specific serial numbers listed in the recall notice. The device is used by physicians for skin cancer lesions.
Verify the model number, software version, and serial numbers against the list provided in the recall notice.
The DermaSensor device might not meet specifications, leading to incorrect results or delays in referring patients who need skin cancer treatment.
Check the model number, software version, and serial numbers against the list provided in the recall notice to see if your device is affected.
The recall notice does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Dermasensor to request your refund or repair — edit it as you like.
Subject: Recall Z-0583-2026 — Dermasensor Dermasensor Hello, I own a Dermasensor that is covered by recall Z-0583-2026 from Dermasensor. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.